Japanese Healthy Male Adult VolunteersPhase 1NCT01253434
E2022 Patch Formulation Single Dose Phase I Study
A Phase 1 study testing E2022 in people with Japanese Healthy Male Adult Volunteers, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Japanese Healthy Male Adult Volunteers
- What is being tested?
- E2022
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2010to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) at Screening is 18.5 kg/m2 or above and less than 25.0 kg/m2: BMI (kg/m2)= weight(kg) ÷ {height(m)× height(m)}
- Subjects who are between 20 and 55 years of age at the time of obtaining written consent.
- Subjects who are willing to and can comply with the conditions described in the study protocol.
Who cannot join
- Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.
- Exposure to any supplements or herbs (including Chinese medicine), or beverages (e.g. alcohol or grapefruit-containing beverages) known to modulate CYP3A4, CYP2C9, CYP2C19, CYP2D6, within 2 weeks before study drug administration.
- Subjects with history of cutaneous hypersensitivity to external preparation, or those who are on another transdermal formulation.
- Subjects who have excessive skin hair around the region to put the patch on.
- Subjects with skin disorder, such as eczema, skin irritation, pigment disorder, injury or scar in the region of patch application, which may have an impact on skin findings.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers.
Read the detailed description
This study is an open-label single site, randomized single dose study in 80 healthy Japanese male volunteers. The study consists of Period I to Period III, a total of 3 periods. In Period I, E2022 patches will be secured with seal. In Period II, single dose of E2022 5 mg tablet will be administered. In Period III, E2022 patches will be applied without seal. The features of the 5 patches will be evaluated in this study.
- Conditions
- Japanese Healthy Male Adult Volunteers
- Being tested
- E2022
- Keywords
- Transdermal Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2022Drug
E2022 Type A patch
E2022Drug
E2022 Type B patch
E2022Drug
E2022 Type C patch
E2022Drug
E2022 Type D patch
E2022Drug
E2022 Type E patch
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E2022 |
| 2 | Experimental | Not described Receives: Drug: E2022 |
| 3 | Experimental | Not described Receives: Drug: E2022 |
| 4 | Experimental | Not described Receives: Drug: E2022 |
| 5 | Experimental | Not described Receives: Drug: E2022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Japanese Healthy Male Adult VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomoo Ogawa, Study director, Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253434
- Sponsor's protocol ID
- E2022-J081-001
- Status last verified
- Aug 2011
- First submitted
- 30 Nov 2010
- Last updated
- 14 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E2022 Patch Formulation Single Dose Phase I Study
- ClinicalTrials.gov ID
- NCT01253434
- Acronym / sponsor ID
- E2022-J081-001
- Conditions
- Japanese Healthy Male Adult Volunteers
- Keywords
- Transdermal Administration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers.
Detailed description
This study is an open-label single site, randomized single dose study in 80 healthy Japanese male volunteers. The study consists of Period I to Period III, a total of 3 periods. In Period I, E2022 patches will be secured with seal. In Period II, single dose of E2022 5 mg tablet will be administered. In Period III, E2022 patches will be applied without seal. The features of the 5 patches will be evaluated in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E2022 |
| 2 | Experimental | Drug: E2022 |
| 3 | Experimental | Drug: E2022 |
| 4 | Experimental | Drug: E2022 |
| 5 | Experimental | Drug: E2022 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) at Screening is 18.5 kg/m2 or above and less than 25.0 kg/m2: BMI (kg/m2)= weight(kg) ÷ {height(m)× height(m)}
- Subjects who are between 20 and 55 years of age at the time of obtaining written consent.
- Subjects who are willing to and can comply with the conditions described in the study protocol.
Key exclusion criteria (5 listed)
- Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.
- Exposure to any supplements or herbs (including Chinese medicine), or beverages (e.g. alcohol or grapefruit-containing beverages) known to modulate CYP3A4, CYP2C9, CYP2C19, CYP2D6, within 2 weeks before study drug administration.
- Subjects with history of cutaneous hypersensitivity to external preparation, or those who are on another transdermal formulation.
- Subjects who have excessive skin hair around the region to put the patch on.
- Subjects with skin disorder, such as eczema, skin irritation, pigment disorder, injury or scar in the region of patch application, which may have an impact on skin findings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E2022E2022 Type A patch | Drug | 1 |
| E2022E2022 Type B patch | Drug | 2 |
| E2022E2022 Type C patch | Drug | 3 |
| E2022E2022 Type D patch | Drug | 4 |
| E2022E2022 Type E patch | Drug | 5 |
Primary outcome
Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomoo Ogawa study director
Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E2022 in people with Japanese Healthy Male Adult Volunteers, run by Eisai Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets. (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.